Research Scientist – Pharmacovigilance

2 - 5 Years
Mumbai

Job Description

Functional Area: Drug Safety and Pharmacovigilance
Primary Duties:
1)Perform triage, completeness, legibility and validity of incoming adverse event case reports (Serious and Non-serious events) originated from clinical and post marketing studies.
2)Assess case reports for seriousness, causality, expectedness and validity of incoming safety information.
3)Ensure an accurate and timely reporting of expedited safety reports to DCGI and applicable Regulatory Authority.
4)Timely follow up with Investigator and other health care professionals for outstanding information.

5) Perform data entry, narrative writing, report scheduling in client owned databases.
6) Coordinate with data management, clinical team and investigational sites for SAE queries reconciliation.
7) Written SAE management plan, SOPs and timely update country specific safety reporting requirement.
8) Get actively involved in discussions, study training meetings for Safety.
9) To Manage queries and discrepancies from Sponsor, IEC/IRB and Regulatory Authority.
10) Provides mentorship to existing and new staff within the department with regard to AE/SAE reporting process and regulatory reporting requirements.

Salary: INR 4,00,000 - 6,00,000 P.A.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:R&D

Role:Research Scientist

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

Company Profile

Pharma Placements Inc.

Pharma Placements Inc. is one of the leading HR consultancy providing manpower to Pharma Industry
View Contact Details+

Recruiter Name:Pharma Placements Team

Contact Company:Pharma Placements Inc.

Telephone:9820360083

Email :pharmaplacement2@gmail.com

Address :F 99, First Floor, B Wing, Express Zone Mall, Opp. Adani Energy, W.E.Highway, Goregaon (E), Mumbai

Website:http://www.pharmaplacements.com